Infection
Conditions
Keywords
infusion therapy, continuous infusions, nephrotoxicity, outpatient parenteral antibiotic therapy, vancomycin
Brief summary
Evaluate the safety and outcomes associated between the two treatment modalities
Detailed description
Assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
Interventions
DRUGVancomycin CI
The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin
DRUGVancomycin II
Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
To assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients at least 18 years of age * Receiving Wake Forest Baptist Health Outpatient parenteral antimicrobial therapy (OPAT) services * Will receive vancomycin therapy from Wake Forest Baptist Health Specialty Home Infusion Pharmacy * Planned therapy with vancomycin in the outpatient setting for at least 2 weeks in duration * Prescribed vancomycin with a frequency of either every 12 hours or every 8 hours dosing at the time of enrollment
Exclusion criteria
* Presence of diseases or conditions known to affect the pharmacokinetics of vancomycin: Pregnancy/Ascites/Burn injury/Cystic fibrosis /Weight greater-than or equal-to 150 kg * Pre-existing leukopenia: White Blood Cell (WBC) \< 4,000 x 103 cells/µL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Nephrotoxicity in Subjects | week 8 | Number of Subjects with any increase in Serum creatinine by 50% from baseline, an increase in Scr by 0.5 mg/dL, or an increase in Scr by 0.3 mg/dL on two consecutive measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Leukopenia in Subjects | week 8 | Number of Subjects with White Blood Cell (WBC) \< 4,000 x 103 cells/µL |
| Number of Infusion-related Reactions | week 8 | Flushing/Erythema /Rash/Red Man Syndrome |
| Number of Serum Vancomycin Measurements Within Therapeutic Range | week 8 | Number of Serum Vancomycin Measurements Within Therapeutic Range If inpatient dose was determined by AUC monitoring: A vancomycin trough that is within 3.0 mcg/mL of the trough that correlated with a therapeutic AUC based on inpatient monitoring - If inpatient dose was not determined by AUC monitoring or vancomycin was initiated as outpatient: A vancomycin trough of 10.0 - 20.0 mcg/mL |
| Number of Participants With Resolutions of Symptoms Associated With the Infection | week 8 | Number of Subjects without need for additional induction therapy beyond the planned end date |
| Number of Participants With Treatment Failures | week 21 | Number of Participants with Persistence, new onset, or worsening local or systemic signs and symptoms of infection |
Countries
United States
Participant flow
Pre-assignment details
1 Subject Screen Failed who never received study treatment
Participants by arm
| Arm | Count |
|---|---|
| Continuous Infusions (CI) Group CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge
Vancomycin CI: The CI group will have their total daily cumulative dose of vancomycin converted to a 24-hour intravenous infusion upon discharge - the CI will begin with the first scheduled OPAT dose of vancomycin | 4 |
| Intermittent Infusion (II) Group Inpatient study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge
Vancomycin II: Study candidates that are randomized to the II group will continue their current intravenous dosing upon discharge | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Continuous Infusions (CI) Group | Total | Intermittent Infusion (II) Group |
|---|---|---|---|
| Age, Continuous | 44 years | 49 years | 57 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants |
| Region of Enrollment United States | 4 participants | 7 participants | 3 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 1 / 4 | 1 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
Number of Nephrotoxicity in Subjects
Number of Subjects with any increase in Serum creatinine by 50% from baseline, an increase in Scr by 0.5 mg/dL, or an increase in Scr by 0.3 mg/dL on two consecutive measurements
Time frame: week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Infusions (CI) Group | Number of Nephrotoxicity in Subjects | 0 Participants |
| Intermittent Infusion (II) Group | Number of Nephrotoxicity in Subjects | 1 Participants |
Secondary
Number of Infusion-related Reactions
Flushing/Erythema /Rash/Red Man Syndrome
Time frame: week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Infusions (CI) Group | Number of Infusion-related Reactions | 0 Participants |
| Intermittent Infusion (II) Group | Number of Infusion-related Reactions | 0 Participants |
Secondary
Number of Leukopenia in Subjects
Number of Subjects with White Blood Cell (WBC) \< 4,000 x 103 cells/µL
Time frame: week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Infusions (CI) Group | Number of Leukopenia in Subjects | 1 Participants |
| Intermittent Infusion (II) Group | Number of Leukopenia in Subjects | 0 Participants |
Secondary
Number of Participants With Resolutions of Symptoms Associated With the Infection
Number of Subjects without need for additional induction therapy beyond the planned end date
Time frame: week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Infusions (CI) Group | Number of Participants With Resolutions of Symptoms Associated With the Infection | 3 Participants |
| Intermittent Infusion (II) Group | Number of Participants With Resolutions of Symptoms Associated With the Infection | 1 Participants |
Secondary
Number of Participants With Treatment Failures
Number of Participants with Persistence, new onset, or worsening local or systemic signs and symptoms of infection
Time frame: week 21
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Infusions (CI) Group | Number of Participants With Treatment Failures | 2 Participants |
| Intermittent Infusion (II) Group | Number of Participants With Treatment Failures | 2 Participants |
Secondary
Number of Serum Vancomycin Measurements Within Therapeutic Range
Number of Serum Vancomycin Measurements Within Therapeutic Range If inpatient dose was determined by AUC monitoring: A vancomycin trough that is within 3.0 mcg/mL of the trough that correlated with a therapeutic AUC based on inpatient monitoring - If inpatient dose was not determined by AUC monitoring or vancomycin was initiated as outpatient: A vancomycin trough of 10.0 - 20.0 mcg/mL
Time frame: week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Infusions (CI) Group | Number of Serum Vancomycin Measurements Within Therapeutic Range | 9 Number of Blood Draws |
| Intermittent Infusion (II) Group | Number of Serum Vancomycin Measurements Within Therapeutic Range | 2 Number of Blood Draws |